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A Look at Treatments for Rosacea

Worst Pills, Best Pills Newsletter article April, 2015

Rosacea is a chronic skin condition found in older adults, usually starting at age 30 to 50. It affects about 13 million Americans.[1] The most common symptom is mild to severe skin redness or flushing — on the cheeks, nose, chin or forehead — which tends to flare up and recede periodically.[2],[3]

While not generally disabling, this highly visible skin condition can lead to serious social and emotional difficulties for some patients.[4]

Only a handful of drugs are approved by...

Rosacea is a chronic skin condition found in older adults, usually starting at age 30 to 50. It affects about 13 million Americans.[1] The most common symptom is mild to severe skin redness or flushing — on the cheeks, nose, chin or forehead — which tends to flare up and recede periodically.[2],[3]

While not generally disabling, this highly visible skin condition can lead to serious social and emotional difficulties for some patients.[4]

Only a handful of drugs are approved by the Food and Drug Administration (FDA) to treat rosacea, but doctors also prescribe many unapproved treatments in an effort to control this distressing condition.[5] Most rosacea drug treatments are not supported by strong evidence, and a few may even make the condition worse in the long term.

Learn how to control this condition effectively while avoiding harmful drug side effects.

Signs and symptoms of rosacea

Rosacea symptoms tend to appear in cycles. During a flare-up of symptoms, blood vessels in the face swell, and the skin becomes irritated and inflamed. This causes redness, swelling, itching or burning sensations, and, in some patients, bumps and lesions that can be mistaken for acne.[6],[7] Symptom flare-ups are often triggered by an irritant, such as heat, cold, wind, skin care products, or even certain foods and drinks.[8]

In mild cases, the redness, bumps and lesions will disappear between symptom flare-ups.[9] However, over time, blood vessels under the skin may become permanently enlarged, resulting in redness that persists between flare-ups. In more severe cases, enlarged blood vessels may be seen as a network of tiny red lines appearing just beneath the skin.[10]

Dry, sensitive eyes are very common in people with rosacea.[11] Most cases of eye irritation due to rosacea involve no more than mild dryness, burning or stinging.[12] However, in rare cases, eyes may become severely inflamed, causing serious damage to the cornea and leading to vision loss.[13]

In uncommon cases, rosacea can involve permanent bulging and swelling of the nose.[14] Men are about 20 times more likely to experience this disfiguring symptom than are women.[15]

Nondrug treatments for rosacea

The first step in treating rosacea is working to prevent symptom flare-ups by identifying triggers and avoiding them.

Proper skin care is also important. Skin should be washed daily using a gentle cleanser and kept free of irritating skin products. People with rosacea often develop dry, scaly skin due to loss of moisture.[16] A gentle moisturizer may help treat and prevent dryness.

Topical drug treatments

Four topical treatments have been approved by the FDA for rosacea symptoms: metronidazole cream (METROCREAM, METROGEL, METROLOTION, NORITATE), azelaic acid gel (FINACEA), brimonidine gel (MIRVASO) and ivermectin cream (SOOLANTRA).

Metronidazole cream and azelaic acid gel are two drugs with antibacterial effects approved to treat bumps and lesions due to rosacea. Both have shown limited effectiveness at reducing redness,[17],[18] although how these drugs work is not entirely clear. In the past, some scientists believed that rosacea was caused by skin bacteria (and thus, the antibiotics would work by killing that bacteria), but studies failed to confirm this theory.[19] It is also possible that the drugs work simply by reducing inflammation, as antibacterials are known to have anti-inflammatory effects.[20],[21]

Brimonidine topical gel was recently approved by the FDA for treatment of the background redness that persists between symptom flare-ups.[22] This medication works by constricting the tiny blood vessels that lie just under the skin.[23] Its effects are only temporary, and redness begins to return after just a few hours.[24] The drug causes symptom flare-ups in some people, and background redness may be worse after the medication wears off.

Ivermectin cream was approved in December 2014 to treat bumps and lesions associated with rosacea.[25] Ivermectin has not been shown to provide greater clinical benefits compared with the antibacterial cream and gel already approved to treat rosacea symptom flare-ups.

The effects of topical antibacterial treatments for rosacea may be only temporary. Because of this, some doctors recommend using these treatments for extended periods.[26]

Yet use of such products to prevent the return of symptoms has not been studied in humans for longer than six months.[27],[28] Long-term use could actually be harmful: Mice exposed to azelaic acid gel on a long-term basis developed more bumps and bulges at treatment sites than those exposed for a limited time,[29] and metronidazole has been shown to cause cancer in animals when given at high doses or over a long period of time.[30]

Antibiotic pills

Many doctors also prescribe antibiotic pills — most frequently tetracycline (ACHROMYCIN V), doxycycline (ACTICLATE, DORYX, DOXTERIC, MONODOX, VIBRAMYCIN) and minocycline (DYNACIN, MINOCIN, SOLODYN) — to treat severe or persistent rosacea symptoms, believing that it is necessary to deliver antibiotics throughout the body to control severe symptoms.[31],[32] However, only one brand of doxycycline, ORACEA, has been FDA-approved for reducing bumps and lesions due to rosacea, and there have not been enough high-quality clinical trials comparing pills with cream treatments to show that pills offer a substantial benefit in reducing symptoms compared with topical treatments alone.[33]

Importantly, overuse of antibiotics can lead bacteria to adapt and become resistant to the drugs, which causes additional problems if patients get subsequent infections. Some doctors wrongly believe that low-dose antibiotic pills are a safer alternative to regular antibiotic pills, because the low-dose pills reduce inflammation without actually killing any bacteria.[34] However, there is evidence from clinical trials to suggest that even low-dose pills can disrupt the body’s natural bacteria, leading to diarrhea and possibly other more serious side effects.[35],[36] And bacteria exposed to such low-dose treatments are more likely to adapt, which only speeds up the development of drug resistance.[37]

Other unproven remedies

Many other rosacea treatments have been proposed, including certain prescription drugs that are FDA-approved to treat acne, over-the-counter treatments such as vitamin C skin products, and home remedies such as cucumber applied in a cooled yogurt paste.[38],[39]

We recommend against using these treatments for rosacea, as they generally have not been studied in high-quality trials, so their safety and effectiveness remain unproven. Also, some of the prescription drugs used to treat acne, including isotretinoin (ACCUTANE), carry dangerous side effects.[40],[41]

Advice for patients

If you are diagnosed with rosacea, the goal of treatment should be to reduce the severity of any immediate symptoms and prevent future flare-ups.

Ask your doctor to prescribe one of the FDA-approved topical antibacterial treatments (metronidazole or azelaic acid) to treat redness and bumps or lesions during symptom flare-ups. Do not use these drugs to prevent symptom flare-ups over a long period of time, as this could worsen symptoms and raise the risk of side effects.

Between flare-ups, prevent symptoms from returning by steering clear of symptom triggers. Keep your skin clean of potential irritants by washing your face carefully each day with a gentle cleanser. Wear protective clothing outdoors or apply a non-irritating sunblock, avoid cosmetics and harsh skincare products, and learn to recognize and avoid food and drinks that can trigger your symptoms.[42] Cigarette smoke and some drugs — including steroids, any drugs that dilate the blood vessels and opioid painkillers — also may play a role in triggering flare-ups and worsening symptoms.[43],[44]

A gentle moisturizer may help to relieve dry skin and protect against moisture loss. If you have trouble finding a non-irritating moisturizer, ask your doctor for a referral to a skin specialist who can recommend a product that is more likely to work for you.

A small number of patients experience increasing redness, burning or other worsening symptoms of rosacea when using prescription skin care products.[45],[46],[47] Before using any new skin care product, prescription or nonprescription, apply the product to a small area of skin and wait at least 24 hours. Do not use the product if it causes itching, burning, increased redness or other signs of irritation.

Because ivermectin has been approved recently, we recommend that you not use it until seven years after its approval, when more about its potential risks likely will be understood. We make this recommendation for all new drugs that do not represent a clinical breakthrough over existing therapies, because most decisions to pull a drug from the market or add a black-box warning are made within seven years of a drug’s approval.

Do not use brimonidine gel to treat redness that occurs in between symptom flare-ups, because it works for only a short period and symptoms may get worse after stopping the drug.

Do not use antibiotic pills, including ORACEA, to treat rosacea or to prevent symptom flare-ups, as using antibiotics in this way promotes the growth of drug-resistant bacteria, and antibiotic pills have not been proven more effective than topical treatments.

To treat dry or irritated eyes, clean your eyelids with warm water twice daily, and carry artificial tears (VISINE TEARS, REFRESH TEARS) to keep your eyes moist.[48] If irritation is severe, ask your doctor to refer you to an ophthalmologist for specialized treatment.[49]

Ultimately, rosacea cannot be cured, but by taking care to protect your skin and using well-tested treatments only when needed, you can minimize the impact of this troubling condition.

References

[1] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-7.

[2] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-7.

[3] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[4] Moustafa F, Lewallen RS, Feldman SR. The psychological impact of rosacea and the influence of current management options. J Am Acad Dermatol. 2014;71:973-80.

[5] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[6] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[7] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[8] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[9] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[10] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[11] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[12] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[13] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[14] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[15] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[16] Del Rosso JQ. Management of cutaneous rosacea: Emphasis on new medical therapies. Expert Opin. Pharmacother. 2014;15(14):2029-2038.

[17] DailyMed. Label: Noritate. Updated 11/14. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=706b09da-6cf9-421d-8e91-f3999474d322. Accessed January 23, 2014.

[18] DailyMed. Label: Finacea. Updated 04/11. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=63773349-0295-4d56-a72e-0d7cade88ddb. Accessed January 23, 2014.

[19] Wollina U. Rosacea and rhinophyma in the elderly. Clinics in Dermatology. 2011;29:61-68.

[20] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-7.

[21] Van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea (review). Cochrane Database of Systematic Reviews. 2011(3). Art. no. CD003262. doi: 10.1002/14651858.CD003262.pub4.

[22] Food and Drug Administration. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (Search “Brimonidine” for approval history)

[23] Food and Drug Administration. Medical review(s): Brimonidine. June 24, 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000MedR.pdf. Accessed January 21, 2015.

[24] DailyMed. Label: Mirvaso. Updated October 2013. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6a4353f-ae69-4214-901f-e5d42a6fbde7. Accessed January 23, 2014.

[25] DailyMed. Label: Soolantra. Updated December 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a. Accessed January 6, 2015.

[26] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[27] Van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea (Review). Cochrane Database of Systematic Reviews. 2011(3). Art. no. CD003262. doi: 10.1002/14651858.CD003262.pub4.

[28] Dahl MV, Katz HI, Krueger GG, et al. Topical metronidazole maintains remissions of rosacea. Arch Dermatol 1998;134(6):679-83.

[29] U.S. National Library of Medicine. FINACEA — azelaic acid gel. Updated April 2011. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=63773349-0295-4d56-a72e-0d7cade88ddb.

[30] DailyMed. Label: Noritate. Updated November 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=706b09da-6cf9-421d-8e91-f3999474d322. Accessed January 23, 2014.

[31] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[32] Van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea (review). Cochrane Database of Systematic Reviews. 2011(3). Art. no. CD003262. doi: 10.1002/14651858.CD003262.pub4.

[33] Van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea (review). Cochrane Database of Systematic Reviews. 2011(3). Art. no. CD003262. doi: 10.1002/14651858.CD003262.pub4.

[34] Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol 2007;(56):791-802.

[35] Food and Drug Administration. Medical Review: 50-805. May 26, 2006. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000_MedR.pdf.

[36] DailyMed. Label: ORACEA. Updated 08/13. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa15c93a-ff4c-447a-8a21-96da506d8997.

[37] Franco BE, Martinez MA, Rodriguez MAS, Wertheimer AI. The determinants of the antibiotic resistance process. Infect Drug Resist. 2009;(2):1-11.

[38] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-217.

[39] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[40] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-217.

[41] Food and Drug Administration. Isotretinoin (marketed as Accutane) capsule information. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm. Accessed January 23, 2014.

[42] Cohen AF, Tiemstra JD. Diagnosis and treatment of rosacea. J Am Board Fam Pract. 2002;15:214-217.

[43] Wollina U. Rosacea and rhinophyma in the elderly. Clinics in dermatology. 2011;29:61-68.

[44] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[45] U.S. National Library of Medicine. Metronidazole topical cream, 0.75%. Updated June 2009. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f6014f9-4a54-47c6-a290-01472e6c0fe7. Accessed January 23, 2014.

[46] Food and Drug Administration. Medical review(s): Brimonidine. June 24, 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000MedR.pdf. Accessed January 23, 2015.

[47] DailyMed. Label: Soolantra. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a. Accessed January 23, 2014.

[48] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.

[49] Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.